Treatment of West Nile Virus With MGAWN1 (PARADIGM)

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Detailed Description:

The objective of this study is to evaluate the safety, efficacy, and pharmacokinetics of MGAWN1 in subjects with West Nile Fever or a syndrome compatible with West Nile Neuroinvasive Disease (WNND) [encephalitis, meningitis, or acute flaccid paralysis]. Subjects can be enrolled based on a syndrome compatible with WNND, and do not need documented West Nile virus infection.

Phase 2, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MGAWN1 in Subjects With Laboratory-documented West Nile Fever or Suspected Central Nervous System Infection Due to West Nile Virus

The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score) [ Time Frame: Study Day 2, 7, 14, 28, and 120 ]

The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:

The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event [ Time Frame: 120 days ]

Includes adverse events considered possibly, probably, or definitely related to study drug

Secondary Outcome Measures
:

The Number of Participants With a Favorable Neurologic Outcome [ Time Frame: Study Day 2, 7, 14, 28, and 120 ]

Favorable neurologic outcome responders are defined as subjects whose Modified Rankin Score is <=2. The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:

The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:

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Have epidemiological factors consistent with West Nile Virus infection (must meet criterion a or b below):

Appropriate time of year for West Nile Virus transmission in region

Travel history to a region where West Nile Virus is active

Develop signs and/or symptoms within 14 days before study enrollment.

If female of childbearing potential or male and in a sexual relationship with a female of childbearing potential, agree (or have partner agree) to practice abstinence or use 2 of the following methods of contraception for 120 days (approximately 4 months) after study drug administration:

Oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches